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Identification of Pathways to Mitigate Immune-Related Adverse Events With Cancer Immunotherapy

NCT04283539 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 255

Last updated 2026-06-16

No results posted yet for this study

Summary

This protocol is a prospective, observational study of participants receiving immunotherapy (checkpoint inhibitors, CPI) for cancer therapy, testing the hypothesis that patients with immune related cutaneous adverse events (ircAEs) have unique immunologic endotypes associated with polarized immune responses.

Conditions

  • Cancer
  • Skin Disease
  • Immunotherapy
  • Patients With Solid Tumors Receiving Immunotherapy With an ICI Will be Randomized to Participate in an SDoH and Side Effects Navigation Program vs. Control

Interventions

DRUG

systemic corticosteroid or biologic

Treatment with systemic corticosteroids or biologic therapies (for corticosteroid refractory patients or these in which corticosteroids are not the treatment of choice)

Sponsors & Collaborators

Principal Investigators

  • Donald Leung, MD, PhD · National Jewish Health

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-23
Primary Completion
2025-03-25
Completion
2026-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04283539 on ClinicalTrials.gov